Dynastat Adverse Reactions

Clinical Trials: The following adverse reactions were reported in patients who received parecoxib (N=5402) in 28 placebo-controlled clinical trials.
Very common (Events occurring ≥10%): Gastrointestinal Disorders: Nausea.
Common (Events occurring ≥1% and <10%): Gastrointestinal Disorders: Abdominal pain, constipation, dyspepsia, vomiting.
General Disorders and Administration Site Conditions: Edema peripheral.
Infections and Infestations: Alveolar osteitis (dry socket).
Nervous System Disorders: Dizziness.
Psychiatric Disorders: Insomnia.
Renal and Urinary Disorders: Oliguria.
Skin and Subcutaneous Tissue Disorders: Sweating increased, pruritis.
Vascular Disorders: Hypotension.
Uncommon (Events occurring ≥0.5% and <1%): Gastrointestinal Disorders: Mouth dry, flatulence.
Musculoskeletal and Connective Tissue Disorders: Back pain.
Cardiac Disorders: Bradycardia.
Infections and Infestations: Pharyngitis.
Skin and Subcutaneous Tissue Disorders: Rash.
Vascular Disorders: Hypertension.
Uncommon to rare (Events occurring <0.5%): Cardiac Disorders: Myocardial infarction.
Ear and Labyrinth Disorders: Earache.
Gastrointestinal Disorders: Esophagitis, gastroesophageal reflux, hypoactive bowel sounds, pancreatitis, perioral swelling.
General Disorders and Administration Site Conditions: Injection site pain, injection site reaction, asthenia.
Immune System Disorders: Anaphylactoid reaction.
Investigations: BUN increased, creatine phosphokinase increased, creatinine increased, LDH increased.
Injury, Poisoning and Procedural Complications: Skin post-operative complications.
Metabolism and Nutrition Disorders: Anorexia, hyperglycemia.
Musculoskeletal and Connective Tissue Disorders: Arthralgia.
Nervous System Disorders: Cerebrovascular disorder.
Psychiatric Disorders: Agitation.
Renal and Urinary Disorders: Renal failure acute.
Respiratory, Thoracic and Mediastinal Disorders: Embolism pulmonary.
Skin and Subcutaneous Tissue Disorders: Ecchymosis, urticaria.
Vascular Disorders: Hypertension aggravated, hypotension postural.
Following coronary artery bypass graft surgery, patients administered parecoxib have a higher risk of adverse events, such as cardiovascular thromboembolic events (e.g., myocardial infarction and cerebrovascular accident), deep surgical infections or sternal wound healing complications.
Post-Marketing Surveillance: In post-marketing experience, the following rare, serious adverse events have been reported in association with the use of parecoxib: Circulatory collapse, erythema multiforme, Stevens-Johnsons syndrome, renal failure and hypersensitivity reactions including anaphylaxis and angioedema (see Precautions).
In post-marketing experience, in addition to the severe cutaneous adverse reaction erythema multiforme and Stevens-Johnsons Syndrome, toxic epidermal necrolysis has been reported in association with the use of valdecoxib and cannot be ruled out for parecoxib.